Financial Performance - For the three and nine months ended September 30, 2025, the company reported net losses of $30.3 million and $75.9 million, respectively[116]. - The net loss for the nine months ended September 30, 2025, was $75.9 million, a 31% increase from the net loss of $57.9 million in the prior period[157]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[137]. - Net cash used in operating activities was $65.6 million for the nine months ended September 30, 2025, compared to $39.0 million for the same period in 2024[174][175]. - The company expects to incur significant operating losses and negative cash flow for the foreseeable future as it continues clinical development[170]. Cash and Financing - The company had cash, cash equivalents, and marketable securities totaling $500.9 million as of September 30, 2025, expected to fund operations for at least twelve months[117]. - As of September 30, 2025, the company had $500.9 million in cash, cash equivalents, and marketable securities[169]. - Net cash provided by financing activities was $170.0 million for the nine months ended September 30, 2025, primarily from the 2025 PIPE Financing[177]. - In October 2025, the company entered into a Sales Agreement to potentially raise up to $200.0 million through an at-the-market equity offering program[171]. - The company anticipates needing additional financing in the future to support ongoing research and development efforts[172]. Research and Development - ORKA-001, the lead program, demonstrated a half-life of approximately 100 days and showed complete inhibition of STAT3 signaling for 24 weeks in a Phase 1 trial[120]. - The Phase 2a clinical trial of ORKA-001, named EVERLAST-A, is expected to enroll approximately 80 patients, with a primary endpoint of PASI 100 at Week 16[121]. - A Phase 2b trial of ORKA-001, named EVERLAST-B, is planned to evaluate three dose levels, with dosing projected to begin before the completion of EVERLAST-A[122]. - ORKA-002, targeting IL-17A and IL-17F, is in Phase 1 trials with plans for a Phase 2 trial in hidradenitis suppurativa in the first half of 2026[124]. - The company expects research and development expenses to increase substantially in the foreseeable future as it continues to invest in its programs[139]. Expenses - Research and development expenses increased by $3.3 million, from $25.7 million for the three months ended September 30, 2024, to $29.0 million for the three months ended September 30, 2025, representing a 13% increase[148]. - Total operating expenses increased by $4.7 million, from $29.4 million for the three months ended September 30, 2024, to $34.1 million for the three months ended September 30, 2025, a 16% increase[146]. - General and administrative expenses rose by $1.4 million, from $3.8 million for the three months ended September 30, 2024, to $5.1 million for the three months ended September 30, 2025, a 36% increase[152]. - Personnel-related expenses in general and administrative increased by $1.3 million, from $2.4 million for the three months ended September 30, 2024, to $3.8 million for the three months ended September 30, 2025, a 55% increase[153]. - For the nine months ended September 30, 2025, total operating expenses increased by 52% to $87.6 million from $57.8 million for the same period in 2024[157]. - Research and development expenses rose by 47% to $73.0 million, up from $49.6 million, with external research expenses increasing by 20% to $45.6 million[159][160]. - General and administrative expenses increased by 77% to $14.6 million from $8.2 million, driven by a 135% rise in personnel-related expenses[162][164]. Corporate Actions - The company completed a merger with Pre-Merger Oruka on August 29, 2024, and changed its name from ARCA biopharma, Inc. to Oruka Therapeutics, Inc.[127]. - The company raised approximately $275.0 million in gross proceeds from a subscription agreement prior to the merger, incurring transaction costs of $20.5 million[128]. - In the 2024 PIPE Financing, the company raised approximately $188.7 million from the sale of 5,600,000 shares at $23.00 per share[130]. - In the 2025 PIPE Financing, the company raised approximately $169.6 million from the sale of 10,933,405 shares at $15.00 per share[132]. Accounting and Compliance - There were no changes to the company's critical accounting policies and significant judgments during the three months ended September 30, 2025[181]. - The company did not have any off-balance sheet arrangements as of September 30, 2025[182]. - The financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that may affect reported amounts of assets and liabilities[180]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[183]. Milestone Payments - The company incurred milestone payments of $7.0 million for ORKA-001 and $4.0 million for ORKA-002 as of September 30, 2025[136]. - The company has incurred a total of $12.0 million in non-refundable milestone payments under each License Agreement upon achieving certain clinical development milestones[135]. - The company has a royalty-bearing, world-wide, exclusive license to develop and commercialize antibodies targeting IL-23 and IL-17A/F under the License Agreements with Paragon[135].
Oruka Therapeutics, Inc.(ORKA) - 2025 Q3 - Quarterly Report